Label: UMCKA COLDCARE SUGAR FREE GRAPE- pelargonium sidoides syrup

  • NDC Code(s): 53499-5794-5
  • Packager: Schwabe North America, Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated October 25, 2019

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active Ingredient:

    PELARGONIUM SIDOIDES 1X

    Inactive Ingredients:

    CITRIC ACID

    ETHYL ALCOHOL (0.6%)

    MALTODEXTRIN

    NATUREAL FLAVOR 

    PURIFIED WATER

    RED CABBAGE JUICE COLOR

    SORBITOL

    GLYCERIN

  • DOSAGE & ADMINISTRATION

    Dosage and Administration:

    Nature's Way Brand:

    Directions:

    For best results, use at first sign of symptoms and continue to use for an additional 48 hours after symptoms cease. 

    Use only with enclosed dosage cup.

    Adults and children 12 years of age and older: take 1 1/2 teaspoon (tsp) (7.5 mL) 3 times daily.
    Children 6 to 11 years of age: take 1 teaspoon (tsp) (5mL)  3 times daily.
    Children under 6 years of age: consult a physician.

    Indications and Usage:

    Shortens duration and reduces severity of symptoms associated with the common cold and throat/sinus/bronchial infections: congestion, cough, hoarseness, sore throat.  

    Purpose:

    Shortens duration and reduces severity of symptoms associated with the common cold and throat/sinus/bronchial infections: congestion, cough,, hoarseness, sore throat.

  • WARNINGS

    Warnings:
    Sore throat warning: severe or persistent sore throat for more than 2 days or if accompanied by a high fever, headache, nausea, vomiting, or rash, consult a physician promptly.

    Ask a doctor before use if you have a persistent or chronic cough that lasts, is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or is accompanied by excessive phlegm (mucus).

    Stop use and ask a doctor if new symptoms occur, symptoms worsen or do not get better within 7 days, fever worsens or lasts more than 3 days, or cough lasts more than 7 days or occurs with rash or persistent headache.

    These could be signs of a serious condition.

    Keep Out of Reach of Children:

    Keep out of the reach of children.

    Ask the Doctor:

    Ask a doctor before use if you have a persistent or chronic cough that lasts, is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or is accompanied by excessive phlegm (mucus).

    Stop use and ask a doctor if new symptoms occur, symptoms worsen or do not get better within 7 days, fever worsens or lasts more than 3 days, or cough lasts more than 7 days or occurs with rash or persistent headache.

    These could be signs of a serious condition.

    Pregnancy or Breast Feeding:

    If pregnant or breast-feeding, ask a healthcare professional before use. 

  • UMCKA ColdCare Sugar Free Grape Flavor (15794)

    15794-Umkca-Sugar-Free-Grape-Syrup-B01.jpg

    15794-Umkca-Sugar-Free-Grape-Syrup-B01.jpg

    15794-Umkca-Sugar-Free-Grape-Syrup-B01.jpg

  • INGREDIENTS AND APPEARANCE
    UMCKA COLDCARE SUGAR FREE GRAPE  
    pelargonium sidoides syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53499-5794
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PELARGONIUM SIDOIDES ROOT (UNII: H6J53HEX8E) (PELARGONIUM SIDOIDES ROOT - UNII:H6J53HEX8E) PELARGONIUM SIDOIDES ROOT1 [hp_X]  in 120 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    ALCOHOL (UNII: 3K9958V90M)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    WATER (UNII: 059QF0KO0R)  
    CABBAGE (UNII: GW0W1Y9I97)  
    SORBITOL (UNII: 506T60A25R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorGRAPE (NATURAL GRAPE FLAVOR) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53499-5794-51 in 1 CARTON09/01/2006
    1120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic09/01/2006
    Labeler - Schwabe North America, Inc (831153908)
    Establishment
    NameAddressID/FEIBusiness Operations
    Schwabe North America831153908manufacture(53499-5794)